Valve Heart Disease
Conditions
Keywords
mechanical heart valve, On-X
Brief summary
The purpose of this pilot study is to obtain both near valve and downstream flow characteristics, using 3D transthoracic echocardiography and 4D flow MRI respectively, in an existing patient population at Northwestern Memorial Hospital, to determine the hinge washout characteristics and downstream flow patterns of the On-X valve and compared to competing designs.
Detailed description
Prospective, concurrent 4D flow Magnetic Resonance Imaging (MRI) and echocardiography of On-X and St Jude Medical (SJM) Masters HP or Carbomedics Carbo-seal or Carbo-seal Valsalva aortic valve replacement (AVR) patients will be performed. Echocardiography analysis will include: valve function (opening angle), pressure gradients, and degree of valve washout. MRI analysis will focus on downstream flow patterns (helicity and vorticity), energy loss, pressure recovery, and measurement of wall shear stress in the anastomosis regions.
Interventions
OTHERMRI
Enrolled patients will complete a non-contrast cardiac MRI
OTHERTransthoracic echocardiography exam
Enrolled patients will complete a transthoracic echocardiography exam.
Sponsors
Northwestern University
CryoLife, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Male and female subjects 18-89 years of age * Patients with aortic valve disease who within the last five years underwent AVR using the On-X aortic valve, SJM Masters HP, or Carbomedics aortic valves.
Exclusion criteria
* Patients contraindicated against MRI * Patients with pacemakers, cochlear (in the ear) implants, or aneurysm clips or patients who have worked with metal * Patients unwilling or unable to give written informed consent * Pregnant women * Prisoners * Patients with an Effective Orifice Area index (EOAi) \<0.85 cm2/m2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Downstream flow patterns (helicity and vorticity) | 3 months | MRI data analysis; Helicity and vorticity graded (1-3) by blinded reviewers. |
| Hinge washout | 3 months | MRI data analysis; Yes/No |
| Energy loss | 3 months | MRI data analysis; Irreversible energy loss quantified.Efforts will include the quantification of turbulent kinetic energy. This is representative of permanent pressure loss. |
| Wall shear stress (WSS) | 3 months | MRI data analysis; WSS, the tangential force exerted by blood flow on the vessel wall, measured in the anastomosis regions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Normalized ESV (mL/m^2) | 3 months | End Systolic Volume |
| Peak Velocity (m/s) | 3 months | — |
| Mean velocity (m/s) | 3 months | — |
| Ejection Fraction (%) | 3 months | — |
| Mean transvalvular pressure gradient (mmHg) | 3 months | — |
| Effective Orifice Area (EOA) | 3 months | — |
| Effective Orifice Area index (EOAi) | 3 months | — |
| Peak transvalvular pressure gradient (mmHg) | 3 months | — |
| Primary EDV (ml) | 3 months | End Diastolic Volume |
| Normalized EDV (ml/m^2) | 3 months | End Diastolic Volume |
| Primary ESV (mL) | 3 months | End Systolic Volume |
Countries
United States
Outcome results
None listed